Vacuum Erection Device in Improving Recovery of Erectile Function in Patients With Prostate Cancer Undergoing Surgery
NCT ID: NCT01660152
Last Updated: 2017-04-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
2 participants
INTERVENTIONAL
2011-09-30
2013-07-17
Brief Summary
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Detailed Description
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I. Determine sexual function and penile morphometric outcomes for the post-robotic-assisted laparoscopic prostatectomy (RALP) patients undergoing daily vacuum therapy using one of two randomized methods and whether these outcomes differ.
SECONDARY OBJECTIVES:
I. Compare compliance rates between the two randomized groups using the compliance questionnaire and a diary collected from patients at each follow up visit.
II. Compare overall patient satisfaction with the recovery procedure between the two randomized groups utilizing the SHIM (Sexual Health Inventory for Men) questionnaire.
OUTLINE: Patients are randomized to 1 of 2 treatment groups.
GROUP A: Patients receive vacuum therapy daily over 10 minutes while holding erection for 2 minutes after undergoing RALP. Patients complete erection process 5 times.
GROUP B: Patients receive vacuum therapy daily over 10 minutes while holding erection for 5 minutes after undergoing RALP. Patients complete erection process 2 times.
After completion of study treatment, patients are followed up at 3, 6, and 12 months.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Group A (vacuum therapy, holding erection for 2 minutes)
Patients receive daily vacuum therapy over 10 minutes while holding erection for 2 minutes after undergoing RALP. Patients complete erection process 5 times. SHIM questionnaire administration will be completed prior to surgery and at 3, 6, 12 months and the compliance questionnaire at 3, 6, 12 months.
Sexual Health Inventory for Men (SHIM) questionnaire administration
Questionnaire will be completed prior to surgery and at 3, 6, 12 months and the compliance questionnaire at 3, 6, 12 months.
management of therapy complications
Receive VED
Daily vacuum therapy
Patients randomized to Group A or Group B following removal of catheter at first post op visit following surger. Daily vacuum therapy for approximately 10 minutes. Depending on which group randomized to erection held for 2 minutes or 5 mintues.
Group B (vacuum therapy, holding erection for 5 minutes)
Patients receive daily vacuum therapy over 10 minutes while holding erection for 5 minutes after undergoing RALP. Patients complete erection process 2 times.Patients complete erection process 5 times. SHIM questionnaire administration will be completed prior to surgery and at 3, 6, 12 months and the compliance questionnaire at 3, 6, 12 months.
Sexual Health Inventory for Men (SHIM) questionnaire administration
Questionnaire will be completed prior to surgery and at 3, 6, 12 months and the compliance questionnaire at 3, 6, 12 months.
management of therapy complications
Receive VED
Daily vacuum therapy
Patients randomized to Group A or Group B following removal of catheter at first post op visit following surger. Daily vacuum therapy for approximately 10 minutes. Depending on which group randomized to erection held for 2 minutes or 5 mintues.
Interventions
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Sexual Health Inventory for Men (SHIM) questionnaire administration
Questionnaire will be completed prior to surgery and at 3, 6, 12 months and the compliance questionnaire at 3, 6, 12 months.
management of therapy complications
Receive VED
Daily vacuum therapy
Patients randomized to Group A or Group B following removal of catheter at first post op visit following surger. Daily vacuum therapy for approximately 10 minutes. Depending on which group randomized to erection held for 2 minutes or 5 mintues.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Undergoing a bilateral nerve sparing robotic prostatectomy
* Pre-operative baseline SHIM total score of greater than or equal to 17
* Presence of a female sexual partner
* Dexterity necessary to operate vacuum pump
Exclusion Criteria
* Has taken or has been prescribed nitrate medication in any form in the last 6 months
* Has a known sensitivity to Phosphodiesterase type 5 inhibitors such as Sildenafil, Tadalafil or Vardenafil
* Men with sickle cell anemia
* Men with insufficient manual dexterity to operate vacuum device
* Men with a history of known penile deformity or Peyronie's disease
* Pre or postoperative androgen therapy
* Pre or postoperative radiation therapy to pelvic area
* Men actively smoking at time of enrollment, 1 pack per day or more
70 Years
MALE
No
Sponsors
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Ohio State University Comprehensive Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Ronney Abaza, MD
Role: PRINCIPAL_INVESTIGATOR
Ohio State University
Locations
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Ohio State University Medical Center
Columbus, Ohio, United States
Countries
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Related Links
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Jamesline
Other Identifiers
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NCI-2012-00997
Identifier Type: REGISTRY
Identifier Source: secondary_id
OSU-11019
Identifier Type: -
Identifier Source: org_study_id
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